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PRIMA Safety profile

In PRIMA, Zejula (niraparib) had a manageable safety profile, maintained over 3.5 years of median follow-up.1,2

For a full list of Adverse Events and Special Warnings and Precautions please click here to view the Summary of Product Characteristics for Zejula (niraparib)

PRIMA Overall population

Incidence of TEAEs and impact on treatment with ZEJULA or placebo in the PRIMA overall population (N=728) after 3.5-year median follow-up:1

TEAEs ZEJULA (n=484) Placebo (n=244)
Grade ≥3, % 72.9 23.0
Led to treatment discontinuation, % 13.8* 2.9†
Led to dose reduction, % 71.7 9.4
Led to dose interruption, % 80.4 20.9
Led to death, % 1.0 0.8

Figure adapted from González-Martín A, et al. 2023.

*Two additional patients who experienced a TEAE leading to a dose interruption subsequently discontinued treatment.
†Includes 1 patient who experienced the adverse event ascites at the time of disease progression and was recorded as discontinuing treatment because of disease progression.

ZEJULA

13.8%

Placebo

2.9%

In PRIMA, 13.8% of patients who received ZEJULA discontinued treatment due to AEs vs 2.9% in the placebo arm1

ZEJULA should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with anti-hypertensive therapy. For suspected MDS/AML or prolonged haematological toxicities, the patient should be referred to a haematologist for further evaluation. If MDS/AML is confirmed ZEJULA, treatment should be discontinued and the patient treated appropriately. In case of PRES, it is recommended to discontinue ZEJULA and to treat specific symptoms including hypertension.3
Please refer to the full SmPC for further information.

SEE PRIMA REPORTED TEAES

Find out more

PRIMA study design

PRIMA efficacy

ZEJULA QoL

ZEJULA (niraparib) is indicated3

  • as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
  • as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Abbreviations

AML, acute myeloid leukaemia; FIGO, Federation of Gynaecology and Obstetrics; MDS, myelodysplastic syndrome; PRES, posterior reversible encephalopathy syndrome; TEAE, treatment-emergent adverse event, AE Adverse Event

References

  1. Gonzàlez-Martín A, et al. Eur J Cancer. 2023;189:112908;
  2. González-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402.
  3. Zejula (niraparib) Summary of Product Characteristics (Last Accessed: May 2024).

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk (UK) or search for MHRA Yellow Card in the Google Play or Apple App store. Adverse events should also be reported to GSK Limited on 0800 221 441 or by email at uksafety@gsk.com.

©2024 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.

May 2024 | PM-GB-NRP-WCNT-220021 (V2.0)